Questionnaire based gastroesophageal reflux disease (GERD ...

Indian J Gastroenterol (May–June 2011) 30(3):108–117
DOI 10.1007/s12664-011-0105-9
REVIEWARTICLE
Questionnaire based gastroesophageal reflux disease
(GERD) assessment scales
V. Pratap Mouli & Vineet Ahuja
Received: 7 December 2010 /Accepted: 15 June 2011 /Published online: 23 July 2011
# Indian Society of Gastroenterology 2011
Abstract Questionnaire based assessment scales for
gastroesophageal reflux disease (GERD) have been
utilized for assessment of the patient’s symptomatology,
assessment of symptom severity and frequency, assessment
of health-related quality of life and for assessment
of response to treatment. A multitude of unidimensional
and multidimensional questionnaires exist for making
symptom assessment and monitoring quality of life in
GERD. Many of the scales meet some of the parameters
of an ideal evaluative GERD specific assessment instrument.
Yet, there are certain shortcomings and challenges
which are faced in development of GERD questionnaires.
This review discusses the features of an ideal symptom
assessment instrument, examines the strengths and
weaknesses of currently available questionnaires.
Keywords Diagnosis . Gastroesophageal reflux disease .
Health-related quality of life . Treatment assessment
The prevalence of gastroesophageal reflux disease (GERD)
ranges from 10% to 30% in the population of Western
countries [1]. There is paucity of data regarding the
magnitude of the problem in India. A recent study has
shown the prevalence of GERD to be 16.2% among the
employees of a large tertiary hospital in North India [2].
V. P. Mouli : V. Ahuja (*)
Department of Gastroenterology and Human Nutrition,
All India Institute of Medical Sciences,
New Delhi 110 029, India
e-mail: vineetahuja2004@gmail.com
GERD as a disease entity has varied presentations. The
symptoms may not correlate with the endoscopic picture.
The patients may present as any of the following:
1. typical heartburn and reflux symptoms with endoscopic
evidence of mucosal injury
2. symptoms of heartburn and reflux but a normal upper
gastrointestinal endoscopy (UGIE)
3. no esophageal reflux symptoms but evidence of
mucosal injury on UGIE or
4. atypical symptoms such as dyspepsia, cough, asthma, etc.
So aptly the 2006 consensus meeting held at Montreal
defined GERD as “a condition that develops when the
reflux of stomach contents causes troublesome symptoms
and/or complications” [3].
Because of these diverse clinical manifestations, diagnosis
of GERD is not easy or straightforward. Traditional
diagnostic modalities such as barium swallow and endoscopy
have a sensitivity of 10% to 50% [4] and 30% to 50%
[5, 6] respectively. 24-h esophageal pH monitoring is also
normal in 6%–15% of patients with abnormal symptom
index and not commonly available [7]. So an objective gold
standard diagnostic test is lacking. In the Indian setting, a
study evaluating the diagnostic algorithm of GERD found
that a combination of omeprazole challenge test, endoscopy
and histology will identify all cases of GERD [8]. This
study concluded that 24-h esophageal pH testing, despite
being the gold standard, has no utility in routine clinical
settings and hence its availability should be limited to
tertiary care settings. The patients were recruited on the
basis of symptom score evaluation (heartburn and/or
regurgitation) highlighting the importance of symptombased
questionnaires in the diagnosis of this disease.

Indian J Gastroenterol (May–June 2011) 30(3):108–117 109
Structured questionnaires for diagnosis of GERD have been
formulated based on the patients’ history. As GERD is a
chronic disease, assessment of quality of life is another
important aspect of the disease evaluation. Questionnairebased
evaluation has played an important role in clinical
trials of GERD. This has been so because symptom
improvement and improvement of health-related quality of
life (HRQOL) are the main goals of treatment of GERD.
The aim of this review is to discuss the features of an
ideal symptom assessment instrument, and to examine the
strengths and weaknesses of currently available questionnaires.
The utility of questionnaires in GERD has been
found in the following settings:
1. assessment of the patient’s symptoms
2. assessment of symptom severity and frequency
3. assessment of HRQOL
4. assessment of response to treatment
For achieving these objectives the questionnaires
should be:
1. sensitive to diagnose the disease
2. easily scored
3. easily understandable
4. easily translatable to local languages
5. able to evaluate the disease as completely as possible,
covering all types of typical and atypical symptoms
6. able to assess changes with therapy over shorter as well
as longer duration
7. self reported/self administered
8. economical
9. psychometrically validated in clinical trials
The questionnaires may be classified into - a) symptom
assessing questionnaires (Table 1), b) health-related quality
of life assessing questionnaires (Table 2), and c) hybrid
questionnaires which assess symptom response as well as
quality of life (Table 3). The symptom assessing questionnaires
are either specific to GERD or wide covering other
allied GI diseases.
Symptom assessment scales in GERD
Symptom scales used for diagnosis of GERD
Greatorex and Thorpe [9] developed the esophageal
symptom questionnaire to assist the diagnosis of GERD.
It contained six items namely heartburn, regurgitation,
dysphagia, bleeding, dyspepsia and vomiting, which were
scored on a 4-point adjectival scale; the questionnaire was
completed by the patient in the presence of the examining
doctor. They found that the questionnaire was valid, but
reliability and responsiveness were not assessed.
Table 1 Scales for symptom assessment in gastroesophageal reflux
disease (GERD)
GERD specific
GERD specific esophageal symptom questionnaire [9]
GERD specific questionnaire by Mold et al. [10]
GERD specific questionnaire by Räihä et al. [11]
GERD questionnaire [12]
Infant gastroesophageal reflux questionnaire (I-GERQ) [13]
Gastroesophageal reflux questionnaire (GERQ) [14]
GERD Activity Index (GRACI) [15]
GERD specific questionnaire by Carlsson et al. [16]
GERD specific questionnaire by Manterola et al. [17]
GERD score [18]
GERD Symptom Assessment Scale (GSAS) [19]
GERD screener [20]
Questionnaire used by Vigneri et al. [21]
Reflux disease diagnostic questionnaire (RDQ) [22]
Chinese GERD Questionnaire (Chinese GERDQ) [23]
Scores for assessment of other diseases along with GERD
Standardized esophageal symptom questionnaire [24]
Questionnaire by Andersen et al. [25]
Gastrointestinal Symptoms Rating Scale (GSRS) [26]
Questionnaire by Ruth et al. [27]
Ulcer esophagitis subjective symptoms scale (UESS) [28]
Digestive health status instrument (DHSI) [29]
Modified bowel disease questionnaire (BDQ) [30]
Table 2 Scales for quality of life assessment in gastroesophageal
reflux disease (GERD)
GERD specific
Gastroesophageal reflux disease health-related quality of life
(GERD-HRQL) [31]
Heartburn - specific quality of life instrument (HBQOL) [32]
GERD specific QoL questionnaire by Jasani et al. [33]
QOL questionnaire in gastroesophageal reflux (Reflux-Qual) [34]
Reflux-qual short-form (RQS) [35]
Work Productivity and Activity Impairment Questionnaire for GERD
(WPAI-GERD) [36]
QoL questionnaire for patients undergoing antireflux surgery
(QOLARS) [37]
GERD-QOL [38]
GI specific
Gastrointestinal quality of life index (GIQLI) [39]
Quality of life in reflux and dyspepsia (QOLRAD) [40]
Patient assessment of upper gastrointestinal disorders (PAGI-QOL) [41]
Generic
Psychological general well-being index (PGWB) [42]
EuroQoL-5 dimensions (EQ-5D) [43]
36-Item short-form general health survey (SF-36) [44]

110 Indian J Gastroenterol (May–June 2011) 30(3):108–117
Table 3 Hybrid scales assessing both symptoms and quality of life in
gastroesophageal reflux disease (GERD)
Questionnaires by Colwell et al. [45] and Mathias et al. [46]
HRQoL batteries [47]
Domestic/International Gastroenterology Surveillance Study
(DIGEST) [48]
Reflux questionnaire (ReQuest) [49]
Nocturnal GERD symptom severity and impact questionnaire
(N-GSSIQ) [50]
Johnsson et al. [12] used four structured and descriptive
questions in their self reported GERD questionnaire. The
description of symptoms rather than using the term heartburn
may have been a factor in improving the predictive value of
this questionnaire, but a positive response to all four questions
was required to achieve a high positive predictive value, thus
limiting its usefulness. Moreover, this questionnaire was
specific for erosive GERD and/or patients with pathological
pH values. This questionnaire was not validated.
Ornstein et al. [13] devised a 138-item questionnaire to
diagnose GERD in infants and to identify potentially
provocative caretaking practices. In a validation study, it
was shown that the questionnaire has high positive and
negative predictive values for diagnosing GERD.
Reidel et al. [24] assessed all patients referred over a
one-year period for clinical esophageal manometry (not
clear) by means of a self-reported questionnaire. Symptoms
assessed were chest pain, dysphagia for solids and liquids,
heartburn, regurgitation. They found esophageal symptoms
to be poor predictors of manometric findings. However the
questionnaire was not validated.
Carlsson et al. [16] used word pictures of symptoms to
design a self-assessment questionnaire that was intended to
identify responders to PPI therapy. They found that the
sensitivity of a scale increased whenever descriptions or word
pictures were used instead of single terms. Prospective
validation of this questionnaire in a primary care population
did not find the questionnaire superior to the physician’s
provisional diagnosis for discriminating omeprazole responders.
The Digestive Health Status Instrument (DHSI) was
designed as a self reported questionnaire incorporating 34
items to assess functional gastrointestinal diseases related to
bowel dysfunction/irritable bowel syndrome, reflux,
dysmotility and pain in primary care settings [29].
Psychometric analyses were performed and multiple types
of reliability, validity and responsiveness were demonstrated
in study populations including community, primary care
and gastroenterology subjects [51].
Symptom scales used for epidemiological studies of GERD
Mold et al. used a self reported GERD specific questionnaire
with 15 items assessing GERD symptoms and
pulmonary symptoms [10]. They found that 14% of elderly
population had at least weekly heartburn and 24% of
elderly population with alkaline reflux had pulmonary
symptoms in contrast to none with acid reflux.
Räihä et al. used a self reported GERD specific
questionnaire designed in Finnish language to study the
prevalence of GERD in elderly population [11]. The
response rate and the completeness of the filling of forms
were found to be high (~ 90%). They found that 54% of
males and 66% of females among the elderly population
had symptoms of GERD at least once a month. However
both these questionnaires were not validated.
Locke et al. developed a GERD specific self reported
GERD questionnaire (GERQ) originally in English
language [14]. They compared the symptoms assessed
by this questionnaire with endoscopy findings and found
that heartburn frequency was associated with esophagitis,
the duration of acid regurgitation was associated with
Barrett’s esophagus and strictures were associated with
dysphagia severity and duration. However the questionnaire
overall was only able to modestly predict endoscopic
findings. The same questionnaire was later on translated
into Spanish language and adapted to the Spanish
population with good reproducibility and concurrent
validity [52].
Manterola et al. developed an observer reported questionnaire
in Spanish language to study the prevalence of GERD in
the general population [17]. Validation of this tool has been
done in a further study and its usefulness was established
[53]. However it’s performance and reliability if translated
into English language was not further investigated.
GERD screener is an interview based questionnaire
assessing three subscales namely heartburn, regurgitation
and medication use and the construct, convergent and
predictive validity of this instrument were demonstrated
[20]. This instrument was practical, short and easily
administered and was intended to be used as a case finding
tool in primary care settings and managed care organizations.
Investigators from the All India Institute of Medical
Sciences, New Delhi used a truncated scale (evaluated
heartburn and regurgitation as a symptom score) originally
developed by Vigneri et al. [21] (evaluated heartburn, pain
and regurgitation as a symptom score) and found that a
symptom score ≥4 had a high diagnostic accuracy for
GERD [8]. This questionnaire was interview based. This
validated score was then used to determine the prevalence
of GERD among the employees of the same tertiary
hospital [2]. This questionnaire was also used to diagnose
GERD and then assess response to therapy in a randomized
controlled trial [54]. The same scale was used in another
population based cross-sectional study which intended to
investigate the prevalence and risk factors of GERD in a
high altitude area [55].

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Ho et al. modified the “Bowel Disease Questionnaire
(BDQ)” originally designed by Talley et al. [56] according
to their local conditions and translated the English version
into Chinese and Malay languages [30]. This questionnaire
was interview based and used to assess various functional
GI disorders. Prevalence of various GI symptoms with
particular mention of reflux-type symptoms was assessed in
a multiracial Asian population in Singapore. Feasibility,
reproducibility and validity of the modified BDQ questionnaire
were also demonstrated.
Andersen et al. developed a self reported questionnaire
in Danish language to detect benign esophageal diseases in
epidemiological studies [25]. Ruth et al. developed a self
reported questionnaire related to various esophageal
diseases in Swedish language to assess the prevalence and
severity of symptoms suggestive of esophageal diseases in
a general population [27]. Both these questionnaires were
neither translated and assessed in English language nor
further validated.
Symptoms scales to assess response to treatment
GERD score is a symptom questionnaire developed to
measure the outcome after the medical and surgical
treatment of GERD [18]. This is a six item questionnaire
administered by an external observer rather than being self
reported. It is used to assess the severity (on a 4-point scale)
and frequency (on a 5-point scale) of six GERD symptoms
namely heartburn, regurgitation, epigastric or chest pain,
epigastric fullness, dysphagia, cough by applying the scale
to patients before and 6 months after treatment. This tool
was validated psychometrically and shown to be reproducible,
valid with significant correlation between the baseline GERD
score and lower esophageal sphincter pressure, 24-hr
esophageal pH, and 8 subscales of the 36-item Short-Form
General Health Survey (SF-36) and responsive to change.
However this scale has certain limitations. It has not
been validated for the assessment of short-term response
of treatment of less than 6 months duration and the
reproducibility over longer periods of time more than
6 months has not been assessed. It doesn’t include
atypical symptoms, is available only in English language
and has to be administered by an external observer.
Gastroesophageal Activity Index (GRACI) is a GERD
specific symptom scale developed by using multiple
logistic regression analysis techniques to correlate clinical
data with a physician’s assessment of GERD activity [15].
The scale has a combination of interview based (12 items)
and patient reported items (5 items noted in a diary daily for
1 week). The questionnaire is available in English language
and is administered at baseline and subsequently at 3-month
intervals. The validity and reliability of the scale were
demonstrated. It was developed as a major outcome
variable in clinical trials. However it needs to be tested in
further clinical trials as its responsiveness has not been
proven conclusively.
GERD Symptom Assessment Scale (GSAS) is a
GERD specific self assessed scale available in English
language and developed to be administered before and
after treatment [19]. It has 15 items including various
symptoms such as bloating, nausea, early satiety, etc.
which usually are not included in other assessment tools.
However it does not include all the atypical symptoms and
nocturnal symptoms. It has been validated and shown to
have acceptable reliability, content and construct validity
and sensitive to changes in severity of symptoms and to
changes over time.
The Reflux Disease Questionnaire (RDQ) was originally
developed to facilitate the diagnosis of GERD in primary
care settings [22]. It is a self administered GERD specific
questionnaire which assessed the frequency and severity of
three parameters namely regurgitation, heartburn and
dyspepsia. The validity, reliability and responsiveness of
this scale have been demonstrated. In contrast to the
original RDQ, a German version was created to assess
treatment response for a period of 1 week [57]. Latter on in
a study of 439 Scandinavian patients randomized to either
esomeprazole or placebo, RDQ has been shown to be
useful to evaluate treatment response [58]. The assessed
time period is over the last 4 weeks at baseline and the last
1 week period in patients being assessed for post-treatment
benefit. This questionnaire was also shown to effectively
differentiate various levels of patient-assessed symptom
severity in comparision to physician-assessed severity of
symptoms. The results were found to be consistent when
the questionnaire was translated to Swedish and Norwegian
languages.
Madan et al. utilized the questionnaire developed to
diagnose GERD in North Indian patients to assess response
to therapy in a randomized controlled trial and found that a
combination of pantoprazole and mosapride was more
effective than pantoprazole alone in providing symptomatic
relief to patients with erosive GERD [54].
The Chinese GERD Questionnaire (Chinese GERDQ)
[23] is a GERD specific, self reported instrument whose
main framework is derived from the GERQ questionnaire
[14]. Few additional questions based on the usual encountered
clinical problems in their respective clinical settings
were added to the original questionnaire and translated into
Chinese language. The final questionnaire is usable in
epidemiological studies and interventional studies of
GERD. Content validity, construct validity, discriminant
validity, reproducibility, test-retest reliability and internal
consistency of the scale were demonstrated. However the
questionnaire is available to be used only in Chinese
language.

112 Indian J Gastroenterol (May–June 2011) 30(3):108–117
The Ulcer Esophagitis Subjective Symptoms Scale is a
self assessed and validated questionnaire with visual
analogue scale for assessment of concerned dimensions in
patients of peptic ulcer disease and esophagitis at baseline
and after 4 weeks of treatment [28]. Thus this scale is not
specific to GERD. It is available only in Swedish language.
The Gastrointestinal Symptom Rating Scale (GSRS) was
originally developed as a interview based tool to measure
the outcomes for irritable bowel syndrome and peptic ulcer
disease [59]. Later on it was modified to a self reported tool
and extended for the assessment of GERD also [26]. Thus
this scale is not GERD specific. It has 15 items combined
into 5 symptom clusters namely reflux, abdominal pain,
indigestion, diarrhea, constipation and scored on a 7-point
Likert scale defined by verbal descriptors. It was made
available for usage in many languages including English.
Psychometric evaluation indicated that the 5 scales of the
GSRS have good internal consistency, reasonable test-retest
reliability, acceptable construct validity and it was proven to
be responsive to treatment in clinical trials [60]. However
the instrument was not found to be very sensitive for
GERD [61].
Quality of life assessment scales in GERD
HRQOL scales specific for GERD
The Gastroesophageal Reflux Disease Health-Related
Quality of Life (GERD-HRQL) questionnaire is a self
assessed, GERD specific scale devised in English language
and is mainly used before and after anti-reflux surgery [31].
It has 10 items scored on 6-point Likert scales addressing
domains like severity of heartburn, conditions of heartburn,
dysphagia, odynophagia, effect of medication and flatulence.
But no extra-esophageal symptoms were included.
This scale has been subjected to only limited psychometric
evaluation. There was no significant correlation between
the GERD-HRQL scores and the eight domains of the
SF-36 scale [62].
The Heartburn-specific Quality of Life instrument is a self
assessed, patient diary based, GERD specific scale, available
in English language and was developed to detect changes in
HRQOL before and after GERD therapy in clinical trials [32].
The questionnaire contains 15 items assessing 6 dimensions
namely diet, mental health, pain, role physical, sleep and
social activity. In a randomized controlled trial comparing
ranitidine vs. placebo its responsiveness, reliability and
validity were demonstrated [63]. However this scale has
not been used widely in clinical trials.
Jasani et al. devised a GERD-specific self-assessed
HRQOL questionnaire consisting of 20 items [33]. But this
scale was not subjected to psychometric evaluation.
Raymond et al. developed a GERD-specific HRQOL
questionnaire (Reflux-Qual) consisting of 37 items assessing
7 dimensions including daily life, discomfort, wellbeing,
physical functioning, anxiety, sleep, food by using
5-point Likert scales [34]. The validity, reliability and
responsiveness of this scale were demonstrated. However
the validation has been performed only for the original
French version of this scale, though it is available in various
languages.
The Reflux-Qual Short-Form measures the HRQOL in
patients with GERD by assessing 5 domains including daily
life, well-being, psychological impact, sleep and eating
using 8 items by means of 5-point Likert scales [35]. It was
devised for use in daily practice. Psychometric evaluation
demonstrated good internal consistency, construct validity,
reliability, discriminant validity and responsiveness. There
was a good concurrent validity regarding the correlation
between the SF-12 scores and the RQS score. However
similar to the Reflux-Qual questionnaire, validation of this
scale has also been performed only for the French version,
though the scale has been translated and made available in
various other languages.
Work Productivity and Activity Impairment Questionnaire
for GERD (WPAI-GERD) is a self-assessed tool
designed to assess absence from work, reduction in
productivity and activities as measured in hours per day
and in percent reduction respectively in patients of GERD
specifically [36]. The discriminant and convergent validity
of the instrument have been demonstrated.
The QOL questionnaire for patients undergoing Antireflux
Surgery (QOLARS) was developed to assess HRQOL
in GERD patients who underwent laparoscopic fundoplication
[37]. The questionnaire consists of 45 items when
administered preoperatively and 50 items when administered
postoperatively and is devised in English language.
The QOLARS questionnaire is a combination of the
European Organization of Research and Treatment of
Cancer quality of life questionnaire (EORTC-QLQ-C30)
[64], the Visick score [65] and a modified GERD-HRQL
[31]. All these scales have been validated. However the
responsiveness of the QOLARS scale has not been reported
clearly.
Chan et al. developed the GERD-specific self-administered
GERD-QOL questionnaire in Chinese language for multidimensional
assessment of quality of life impairment because of
GERD before and after treatment [38]. It is a pure HRQOL
instrument with no symptom-specific questions. The final
questionnaire had 16 items grouped into four subscales
including daily activity, treatment effect, diet and psychological
well-being assessed by a 5-point Likert scale. Psychometric
validation was performed and internal consistency,
test-retest reliability, construct validity, discriminant validity,
responsiveness were demonstrated. The questionnaire was

Indian J Gastroenterol (May–June 2011) 30(3):108–117 113
translated into English and linguistic validation was done.
However the English version of the GERD-QOL questionnaire
needs to validated further in English population and
other ethnic groups to confirm its robustness for multiethnic
studies.
HRQOL scales specific for various GI diseases
The Gastrointestinal Quality of Life Index (GIQLI) was
developed to measure HRQOL in various GI diseases and
not specific for GERD [39]. It is a system specific
questionnaire assessing how frequently a symptom has
interfered with the patients’ HRQOL during the past
2 weeks. It consists of 36 items assessing 5 domains
namely core symptoms, physical, emotional, social and
disease-specific items and scoring is done on a 5-point
Likert scale. The GIQLI scale has been validated in a
variety of research settings. In the patients of GERD, it was
shown to be responsive after antireflux surgery. It is
available and validated in various languages including
English. The inability to discriminate between different GI
diseases and that more than half the items in the
questionnaire are related to the symptom frequency rather
than HRQOL are the main limitations of this scale.
The Quality of Life in Reflux and Dyspepsia (QOLRAD)
scale is a self-assessed questionnaire developed to evaluate
patients with GERD and dyspepsia [40]. It consists of 25
items assessing the domains of emotional stress, sleep
disturbance, food and drink problems, physical and social
functioning and vitality. The degree of distress and frequency
of the patients’ feelings during the last week are assessed by
a 7-point Likert scale. Psychometric evaluation has been
performed and the validity, reliability and responsiveness of
this scale have been demonstrated. The QOLRAD scale
showed a high concurrent validity when compared to the
respective domains of the SF-36 or GSRS scales [40, 66]. It
was validated and made available in various languages
including English. Presence of more than one HRQOL
domain in some of the subscales of this instrument may pose
problems in clinical studies.
The Patient Assessment of upper Gastrointestinal
disorders (PAGI-QOL) has been designed to measure the
HRQOL in patients of upper GI disorders [41]. The
questionnaire can be either self-administered or interview
administered and used to assess the patients’ HRQOL in the
last 2 weeks. It consists of 30 items assessing 5 domains
including daily activities, clothing, diet and food habits,
relationship, and psychological well-being and distress with
the scoring done on a 6-point Likert scale. Only the initial
validation studies are available. It has ability to differentiate
various GI disorders is yet to be demonstrated. It was
translated and made available in many languages including
English but validated in only few of them. Further
validation studies in a broader population are needed for
this instrument.
Generic HRQOL scales
The Psychological General Well-Being (PGWB) Index is a
generic QOL instrument originally developed in healthy
populations to measure subjective psychological well-being
and distress [42]. It is a self-assessed questionnaire
consisting of 22 items covering 6 dimensions of HRQOL
including anxiety, depressed mood, positive well-being,
self-control, general health and vitality, all these scored on a
6-point Likert scale. It assesses the HRQOL over the last
4 weeks. It has been shown to have excellent reliability and
validity in studies of GERD and upper gastrointestinal
diseases [42, 67]. It is useful for comparison when the
construct validity and responsiveness of a new scale are
tested. It is available, validated and being used in many
languages and countries. That this scale doesn’t cover all
the essential core domains of a HRQOL measure and
instead focuses only on psychological or emotional
domains and inability to distinguish between the underlying
diseases are its limitations.
The EuroQOL-5 Dimensions (EQ-5D) is a selfadministered
questionnaire available worldwide and in
many languages [43]. It was developed as a generic
measure of health status and is useful in describing and
evaluating HRQOL. However its main role is in generating
cross-national comparisons for economic evaluations, thus
it is useful for calculating quality-adjusted life years
(QALYs) for pharmaco-economic studies. It is not considered
to be a sensitive tool in disease-based outcome research.
Adequate validation is not available for this scale.
Thirty-six-Item Short-Form General Health Survey
(SF-36) is a self-reported, generic HRQOL survey widely
used in primary care settings and in various chronic diseases
including GERD [44]. It consists of 8 domains covering
physical function, role limitations - physical, bodily pain,
vitality, general health perceptions, social functioning, role
limitations - emotional, and mental health assessed by means
of 36 items in the questionnaire. It has been demonstrated in
various studies to have excellent reliability, content validity,
construct validity and responsiveness [68]. It is available and
validated in various languages including English. The
standard SF-36 has a recall period of the last 4 weeks. A
different version with a recall period of 1 week has also been
developed to assess more rapid treatment effects. SF-36 is
used to compare between subgroups of patients and across
the general population. It has also been used as a gold
standard in various studies done for validation of other
HRQOL questionnaires. As the scale is generic and
multipurpose, it is recommended that it be used with a more
specific questionnaire while assessing the HRQOL in a

114 Indian J Gastroenterol (May–June 2011) 30(3):108–117
particular disease [69]. However such an approach requires
more manpower as well as is time consuming. Though more
practicable versions like SF-12 and SF-20 have been
developed, they have been used only in few studies as in
the case of the former or not used at all as in the case of the
SF-20 scale. Also the reliability and validity of the SF-12 are
slightly lower compared to that of the SF-36, but sufficient
for large sample studies [70].
Hybrid scales assessing both symptoms and quality
of life
Colwell et al. [45] and Mathias et al. [46] developed an
assessment tool for patients of erosive GERD, which
measures quality of life as well as symptom frequency
and distress, sleep problems, work disability and treatment
satisfaction. It was shown to have acceptable reliability and
validity. Another version of the same questionnaire is the
HRQOL batteries developed to measure HRQOL in
patients with symptomatic non-erosive GERD patients
[47]. The HRQOL batteries questionnaire contains demographic
items, two domains derived from the SF-12 namely
physical component summary and mental component
summary, six other domains assessing the frequency and
bothersomeness of general GERD symptoms, symptoms
related to eating, social restrictions, problems with sleep,
work disability and treatment satisfaction. Psychometric
evaluation has been done and the internal consistency,
construct validity and responsiveness have been demonstrated.
The correlations between the changes in HRQOL
and change in heartburn symptoms were found to be low to
moderate. Both these questionnaires are available in
English.
The Domestic/International Gastroenterology Surveillance
Study (DIGEST) questionnaire was designed to determine the
3 months prevalence of upper GI symptoms and the impact of
these symptoms on HRQOL [48]. The questions in this
instrument pertain to several gastrointestinal symptoms,
socio-demographic data and quality of life for upper
gastrointestinal diseases. The internal consistency and
test-retest reliability have been demonstrated, but the
responsiveness was not assessed. The main limitation of this
scale is its length due to which it was not found to be
conducive for routine use in clinical trials [71].
ReQuest (Reflux Questionnaire) is a scale designed as
a diary to be used by patients to quantify their total GERD
symptoms daily [49]. The frequency and intensity of seven
dimensions namely acid complaints, upper abdominal/
stomach complaints, lower abdominal/digestive complaints,
nausea, sleep disturbances, other complaints and general
well-being are assessed. A total of 67 symptom descriptions
are incorporated in these seven dimensions. This questionnaire
is self-administered and is available in 30 different
languages. Two subscales of the ReQuest have been
designed namely the ReQuest-GI and ReQuest-WSO,
which measure symptoms traditionally associated with
reflux and with general well-being, respectively, and permit
these to be quantified and tracked independently. The
ReQuest/LA-classification is developed by integrating
the ReQuest-GI subscale with the modified Los Angeles
scale used to grade esophagitis seen at endoscopy [72]. This
tool allows both the symptoms and endoscopy appearances
to be assessed in a single scale and thus complete remission
of symptom relief as well as endoscopic healing can be
identified. Such integrated indices help in standardization
of clinical assessments and simplify comparison of results
of different clinical trials. As minor degrees of reflux are
common among healthy individuals, a ‘GERD symptom
threshold’ has been calculated in a large population using
ReQuest [73]. Recognizing this will help in targeting a
more realistic end point in clinical trials rather than the
difficult ‘complete absence’ of symptoms. For day-to-day
clinical practice, a simplified version of the ReQuest has
been devised and is referred to as ReQuest in Practice
[74]. Psychometric evaluation and validation of ReQuest
and its 2 subscales in both patients with erosive esophagitis
[75] and nonerosive reflux disease [76] have demonstrated
a high internal consistency, test-retest reliability, and
responsiveness.
Spiegel et al. developed and validated an instrument in
English to assess the severity and impact of nocturnal
symptoms of GERD [50]. The Nocturnal Gastroesophageal
reflux disease symptom severity and impact
questionnaire (N-GSSIQ) included 20 items and three
subscales namely, nocturnal GERD symptoms, morning
impact of nocturnal GERD, and concern about nocturnal
GERD. The internal consistency, reliability and validity
were demonstrated. The briefness of the questionnaire is an
added advantage and it can be used either alone or in
combination with other instruments for a more comprehensive
assessment of patient-reported outcomes.
Conclusions
A multitude of unidimensional and multidimensional
questionnaires exist for making symptom assessment and
monitoring quality of life in GERD. Many of the scales
meet some of the parameters of an ideal evaluative GERD
specific assessment instrument. Yet, there are certain shortcomings
and challenges that are faced in development of
GERD questionnaires. Primarily the development of the
ideal assessment instrument is impeded by some of the
inherent clinical features of GERD. There is no clear
consensus regarding which symptoms constitute a diagnosis

Indian J Gastroenterol (May–June 2011) 30(3):108–117 115
or how to define response to the treatment in managing
patients with GERD. Furthermore, although many GERD
patients may manifest with typical symptoms, such as
heartburn and acid regurgitation, others may predominantly
complain of atypical symptoms, such as epigastric pain or
pressure, nausea/vomiting, hoarseness, chest pain, and
wheezing. The symptoms most often used for the diagnosis
of GERD i.e. heartburn and regurgitation are highly specific
(89% and 95%, respectively), but have low sensitivity
(38% and 6%, respectively) leading to a trade-off while
making a diagnostic assessment [5].
The period of time that outcome measures are looked for
is referred to as the time frame. This is prone to recall bias.
One month is the maximum time frame which ensures a
good balance between education of recall bias and having
appropriate information on outcome measures [77].
In summary, amongst the available assessment scales
there is no perfect evaluative scale. In the last decade there
has been significant progress in developing proper tools
that provide better assessment of symptom change but the
sensitivity to show daily alterations is not high. GERD
studies should utilize questionnaires based on unidimensional
or multidimensional outcome measures that assess
both symptom frequency and severity and have proven
validity, reliability and responsiveness.
References
1. Holtmann G. Reflux disease: the disorder of the third millennium.
Eur J Gastroenterol Hepatol. 2001;13 suppl 1:S5–11.
2. Sharma PK, Ahuja V, Madan K, et al. Prevalence, severity, and
risk factors of symptomatic gastroesophageal reflux disease
among employees of a large hospital in Northern India. Indian J
Gastroenterol. 2010; Nov 9. [Epub ahead of print].
3. Vakil N, van Zanten SV, Kahrilas P, Dent J, Jones R, Global
Consensus Group. The Montreal definition and classification of
gastroesophageal reflux disease: A global evidence-based consensus.
Am J Gastroenterol. 2006;101:1900–20. quiz 1943.
4. Wu WC. Ancillary tests in the diagnosis of gastroesophageal
reflux disease. Gastroenterol Clin North Am. 1990;19:671–82.
5. Klauser AG, Schindlbeck NE, Müller-Lissner SA. Symptoms in
gastro-oesophageal reflux disease. Lancet. 1990;335:205–8.
6. Kaul B, Halvorsen T, Petersen H, et al. Gastrooesophageal reflux
disease. Scintigraphic, endoscopic, and histologic considerations.
Scand J Gastroenterol. 1986;21:134–8.
7. McDonald JWD, Burroughs AK, Feagan BG, Fennetry MB.
Evidence-Based Gastroenterology and Hepatology, 3rd ed. UK:
John Wiley and Sons Ltd; Sep 2010. p. 25.
8. Madan K, Ahuja V, Dutta Gupta S, et al. Impact of 24-hr
oesophageal pH monitoring on the diagnosis of gastroesophageal
reflux disease: defining the gold standard. J Gastroenterol
Hepatol. 2005;20:30–7.
9. Greatorex R, Thorpe JA. Clinical assessment of gastroesophageal
reflux by questionnaire. Br J Clin Pract. 1983;37:133–5.
10. Mold JW, Reed LE, Davis AB, et al. Prevalence of gastroesophageal
reflux in elderly patients in a primary care setting. Am J Gastroenterol.
1991;8:965–70.
11. Raiha IJ, Impivaara O, Seppala M, et al. Prevalence and
characteristics of symptomatic gastroesophageal reflux disease in
the elderly. J Am Geriatr Soc. 1992;40:1209–11.
12. Johnsson F, Roth Y, Damgaard Pedersen NE, et al. Cimetidine
improves GERD symptoms in patients selected by a validated
GERD questionnaire. Aliment Pharmacol Ther. 1993;7:81–6.
13. Orenstein SR, Cohn JF, Shalaby TM, et al. Reliability and validity
of an infant gastroesophageal reflux questionnaire. Clin Pediatr
(Phila). 1993;32:472–84.
14. Locke GR, Talley NJ, Weaver AL, et al. A new questionnaire for
gastroesophageal reflux disease. Mayo Clin Proc. 1994;69:
539–47.
15. Williford WO, Krol WF, Spechler SJ. Development for and results
of the use of a gastroesophageal reflux disease activity index as an
outcome variable in a clinical trial. VA Cooperative Study Group
on Gastroesophageal Reflux Disease (GERD). Control Clin Trials.
1994;15:335–48.
16. Carlsson R, Dent J, Bolling-Sternevald E, et al. The usefulness of
a structured questionnaire in the assessment of symptomatic
gastroesophageal reflux disease. Scand J Gastroenterol.
1998;33:1023–9.
17. Manterola C, Munoz S, Grande L, et al. Construction and
validation of a gastroesophageal reflux symptom scale. Preliminary
report. Rev Med Chil. 1999;127:1213–22.
18. Allen CJ, Parameswaran K, Belda J, et al. Reproducibility,
validity, and responsiveness of a disease-specific symptom questionnaire
for gastrooesophageal reflux disease. Dis Oesophagus.
2000;13:265–70.
19. Rothman M, Farup C, Stewart W, et al. Symptoms associated with
gastroesophageal reflux disease: development of a questionnaire
for use in clinical trials. Dig Dis Sci. 2001;46:1540–9.
20. Ofman JJ, Shaw M, Sadik K, et al. Identifying patients with
gastroesophageal reflux disease. Dig Dis Sci. 2002;47:1863–9.
21. Vigneri S, Termini R, Leandro G, et al. A comparision of five
maintenance therapies for reflux oesophagitis. N Engl J Med.
1995;333:1106–10.
22. Shaw MJ, Talley NJ, Beebe TJ, et al. Initial validation of a
diagnostic questionnaire for gastroesophageal reflux disease. Am J
Gastroenterol. 2001;96:52–7.
23. Wong WM, Lam KF, Lai KC, et al. A validated symptoms
questionnaire (Chinese GERDQ) for the diagnosis of gastrooesophageal
reflux disease in the Chinese population. Aliment
Pharmacol Ther. 2003;17:1407–13.
24. Reidel WL, Clouse RE. Variations in clinical presentation of
patients with oesophageal contraction abnormalities. Dig Dis Sci.
1985;30:1065–71.
25. Andersen LI, Madsen PV, Dalgaard P, et al. Validity of clinical
symptoms in benign oesophageal disease, assessed by questionnaire.
Acta Med Scand. 1987;221:171–7.
26. Revicki DA, Wood M, Wiklund I, et al. Reliability and validity of
the gastrointestinal symptom rating scale in patients with
gastroesophageal reflux disease. Qual Life Res. 1998;7:75–83.
27. Ruth M, Mansson I, Sandberg N. The prevalence of symptoms
suggestive of oesophageal disorders. Scand J Gastroenterol.
1991;26:73–81.
28. Dimenäs E, Glise H, Hallerback B, et al. Quality of life in patients
with upper gastrointestinal symptoms. An improved evaluation of
treatment regimens? Scand J Gastroenterol. 1993;28:681–7.
29. Shaw M, Talley NJ, Adlis S, et al. Development of a digestive
health status instrument: tests of scaling assumptions, structure
and reliability in a primary care population. Aliment Pharmacol
Ther. 1998;12:1067–78.
30. Ho KY, Kang JY, Seow A. Prevalence of gastrointestinal
symptoms in a multiracial Asian population, with particular
reference to reflux-type symptoms. Am J Gastroenterol.
1998;93:1816–22.

116 Indian J Gastroenterol (May–June 2011) 30(3):108–117
31. Velanovich V, Vallance SR, Gusz JR, et al. Quality of life scale for
gastroesophageal reflux disease. J Am Coll Surg. 1996;183:217–24.
32. Young TL, Kirchdoerfer LJ, Osterhaus JT. A development and
validation process for a disease-specific quality of life instrument.
Drug Inf J. 1996;30:185–93.
33. Jasani K, Piterman L, McCall L. Gastrooesophageal reflux and
quality of life. Patient’s knowledge, attitudes and perceptions.
Aust Fam Physician. 1999;28 Suppl 1:S15–8.
34. Raymond JM, Marquis P, Bechade D, et al. Assessment of quality
of life of patients with gastroesophageal reflux. Elaboration and
validation of a specific questionnaire. Gastroenterol Clin Biol.
1999;23:32–9.
35. Amouretti M, Nalet B, Robaszkiewicz M, et al. Validation of the
short-form REFLUX-QUAL (RQS), a gastro-oesophageal reflux
disease (GERD) specific quality of life questionnaire. Gastroenterol
Clin Biol. 2005;29:793–801.
36. Wahlqvist P, Carlsson J, Stalhammar NO, et al. Validity of a
work productivity and activity impairment questionnaire for
patients with symptoms of gastro-oesophageal reflux disease
(WPAI-GERD) — results from a cross-sectional study. Value
Health. 2002;5:106–13.
37. Zeman Z, Rozsa S, Tihanyi T, et al. Psychometric documentation
of a quality-of-life questionnaire for patients undergoing antireflux
surgery (QOLARS). Surg Endosc. 2005;19:257–61.
38. Chan Y, Ching JYL, Cheung MY, et al. Development and
validation of a disease-specific quality of life questionnaire for
gastro-oesophageal reflux disease: the GERD-QOL questionnaire.
Aliment Pharmacol Ther. 2010;31:452–60. Epub 2009 Oct 31.
39. Eypasch E, Williams JI, Wood-Dauphinee S, et al. Gastrointestinal
quality of life index: development validation and application of a
new instrument. Br J Surg. 1995;82:216–22.
40. Wiklund IK, Junghard O, Grace E, et al. Quality of life in reflux
and dyspepsia patients. Psychometric documentation of a new
disease-specific questionnaire (QOLRAD). Eur J Surg Suppl.
1998;583:41–9.
41. De la Loge C, Trudeau E, Marquis P, et al. Cross-cultural
development and validation of a patient self-administered questionnaire
to assess quality of life in upper gastrointestinal
disorders: the PAGI-QOL. Qual Life Res. 2004;13:1751–62.
42. Dupuy HJ. The Psychological General Well-Being (PGWB)
Index. In: Wender NK, Mattson ME, Furberg CD, et al., eds.
Assessment of Quality of Life in Clinical Trials of Cardiovascular
Therapies. New York: Le Jacq; 1984. p. 170–83.
43. Group EuroQol. EuroQol - a new facility for measurement of
health related quality of life. Health Policy. 1990;16:199–208.
44. McHorney CA, Ware Jr JE, Lu JF, Sherbourne CD. The MOS
36-item short-form health survey (SF-36). III. Tests of data quality,
scaling assumptions, and reliability across diverse patient groups.
Med Care. 1994;32:40–66.
45. Colwell HH, Mathias SD, Pasta DJ, et al. Development of a
health-related quality-of-life questionnaire for individuals with
gastroesophageal reflux disease: a validation study. Dig Dis Sci.
1999;44:1376–83.
46. Mathias SD, Castell DO, Elkin EP, et al. Health-related quality of
life of patients with acute erosive reflux oesophagitis. Dig Dis Sci.
1996;41:2123–9.
47. Mathias SD, Colwell HH, Miller DP, et al. Health-related qualityof-life
and quality-days incrementally gained in symptomatic
nonerosive GERD patients treated with lansoprazole or ranitidine.
Dig Dis Sci. 2001;46:2416–23.
48. Eggleston A, Farup C, Meier R. The domestic/international
gastroenterology surveillance study (DIGEST): design, subjects.
All patients referred over a one-year period for clinical oesophageal
manometry were asked to carefully characterize their oesophageal
symptoms on a self-report questionnaire and methods. Scand J
Gastroenterol Suppl. 1999;231:9–14.
49. Bardhan KD, Stanghellini V, Armstrong D, et al. Evaluation of
GERD symptoms during therapy. Part I. Development of the new
GERD questionnaire ReQuest TM. Digestion. 2004;69:229–37.
50. Spiegel BM, Roberts L, Mody R, et al. The development and
validation of a nocturnal gastro-oesophageal reflux disease
symptom severity and impact questionnaire for adults. Aliment
Pharmacol Ther. 2010;32:591–602. Epub 2010 Jun 2.
51. Shaw MJ, Beebe TJ, Adlis SA, et al. Reliablity and validity of the
digestive health status instrument in samples of community,
primary care, and gastroenterology patients. Aliment Pharmacol
Ther. 2001;15:981–7.
52. Moreno Elola-Olaso C, Rey E, Rodríguez-Artalejo F, et al.
Adaptation and validation of a gastrooesophageal reflux questionnaire
for use on a Spanish population. Rev Esp Enferm Dig.
2002;94:745–58.
53. Manterola C, Munoz S, Grande L, et al. Initial validation of a
questionnaire for detecting gastrooesophageal reflux disease in
epidemiological settings. J Clin Epidemiol. 2002;55:1041–5.
54. Madan K, Ahuja V, Sharma MP, et al. Comparision of efficacy of
pantoprazole alone versus pantoprazole plus mosapride in therapy
of gastroesphageal reflux disease: a randomized trial. Dis
Oesophagus. 2004;17:274–8.
55. Kumar S, Ahuja V, Saraya A, et al. Population based study to
assess prevalence and risk factors of gastroesophageal reflux
disease in a high altitude area. Indian J Gastroenterol 2011;30:
doi:10.1007/s12664-010-0065-5.
56. Talley NJ, Phillips SF, Melton LJ, et al. A patient questionnaire to
identify bowel disease. Ann Intern Med. 1989;11:671–4.
57. Nocon M, Kulig M, Leodolter A, et al. Validation of the reflux
disease questionnaire for a German population. Eur J Gastroenterol
Hepatol. 2005;17:229–33.
58. Shaw M, Dent J, Beebe T, et al. The reflux disease questionnaire:
a measure for assessment of treatment response in clinical trials.
Health Qual Life Outcomes. 2008;6:31.
59. Svedlund J, Sjodin I, Dovetall G. GSRS-a clinical rating scale for
gastrointestinal symptoms in patients with irritable bowel syndrome
and peptic ulcer disease. Dig Dis Sci. 1988;33:129–34.
60. Talley N, Fullerton S, Junghard O, et al. Quality of life in patients
with endoscopy-negative heartburn: reliability and sensitivity of
disease-specific instruments. Am J Gastroenterol. 2001;96:
1998–2004.
61. Stanghellini V, Armstrong D, Monnikes H, et al. Systematic
review: do we need a new gastro-oesophageal reflux disease
questionnaire? Aliment Pharmacol Ther. 2004;19:463–79.
62. Velanovich V. Comparison of generic (SF-36) vs. disease-specific
(GERD-HRQL) quality-of-life scales for gasro-oesophageal reflux
disease. J Gastrointest Surg. 1998;2:141–5.
63. Rush DR, Stelmach WJ, Young TL, et al. Clinical effectiveness and
quality of life with ranitidine vs placebo in gastro-oesophageal reflux
disease patients: a clinical experience network (CEN) study. J Fam
Pract. 1995;41:126–36.
64. Aaronson NK, Ahmedzai S, Bergman B, et al. The European
Organization for Research and Treament of Cancer QLQ-C30: a
quality-of-life instrument for use in international clinical trials in
oncology. J Natl Cancer Inst. 1993;85:365–76.
65. Visick AH. A study of the failures after gastrectomy. Ann R Coll
Surg Engl. 1948;3:184–226.
66. Kleinman L, Leidy NK, Crawley J, et al. A comparative trial of
paper-and-pencil vs. computer administration of the quality of life
in reflux and dyspepsia (QOLRAD) questionnaire. Med Care.
2001;39:181–9.
67. Naughton MJ, Wiklund I. A critical review of dimension-specific
measures of health-related quality of life in cross-cultural research.
Qual Life Res. 1993;2:397–432.
68. McHorney CA, Ware JE, Lu JFR, et al. The MOS 36-Item Short-
Form Health Survey (SF-36): III. tests of data quality, scaling

Indian J Gastroenterol (May–June 2011) 30(3):108–117 117
assumptions and reliability across diverse patient groups. Med
Care. 1994;32:40–66.
69. Korolija D, Sauerland S, Wood-Dauphinee S, et al. European
Association for Endoscopic Surgery. Evaluation of quality of life
after laparoscopic surgery: evidence-based guidelines of the European
Association for Endoscopic Surgery. Surg Endosc. 2004;18:879–97.
70. Ware JE, Kosinski M, Keller SD. A 12-Item Short-Form Health
Survey: construction of scales and preliminary tests of reliability
and validity. Med Care. 1996;34:220–33.
71. Fraser A, Delaney B, Moayyedi P. Symptom-based outcome
measures for dyspepsia and GERD trials: a systematic review.
Am J Gastroenterol. 2005;100:442–52.
72. Bardhan K, Armstrong D, Fass R, et al. The ReQuestt/
LA-classification: a novel integrated approach for the comprehensive
assessment of treatment outcome of gastrooesophageal reflux disease
(GERD). Can J Gastroenterol. 2005;19 suppl C:R.0031.
73. Stanghellini V, Armstrong D, Monnikes H, et al. Determination of
ReQuest based symptom thresholds to define symptom relief in
GERD clinical studies. Digestion. 2005;71:145–51.
74. López LH, Schneider OP, Vargas AJ, et al. Effectiveness of
pantoprazole magnesium dihydrate in the treatment of symptoms
in gastroesophageal reflux disease. Gut. 2006;55 Suppl V:A275.
75. Mönnikes H, Bardhan KD, Stanghellini V, et al. Evaluation of
GERD symptoms during therapy. Part II. Psychometric evaluation
and validation of the new questionnaire ReQuestTM in erosive
GERD. Digestion. 2004;69:238–44.
76. Bardhan KD, Stanghellini V, Armstrong D, et al. International
validation of ReQuestTM in patients with endoscopy-negative
gastro-oesophageal reflux disease. Aliment Pharmacol Ther.
2004;20:891–8.
77. McColl E. Best practice in symptom assessment: A review. Gut.
2004;53 Suppl 4:iv49–54.